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What is the Best Way to Supervise the Quality of Medical Devices? Searching for a Balance Between ex-ante and ex-post Regulation

Published online by Cambridge University Press:  20 January 2017

Shanta Marjolein Singh
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Abstract

This article discusses the legal remedies available for Competent Authorities, patients and healthcare professionals to prevent harmful incidents involving medical devices. It outlines a theoretical framework for ex-ante and ex-post regulation of medical devices. It then focuses on certain aspects of ex-post regulation. Participation by Competent Authorities with a supervisory role, healthcare professionals and patients in ex-post regulatory legal processes is analysed in the light of the current European Union legal framework and the revised framework proposed by the European Commission. It also discusses whether the proposed new legal framework enables the Competent Authorities, patients and healthcare professionals to prevent the harm caused by unsafe medical devices. Ex-ante regulation might prevent the entrance on the market of unsafe devices whereas ex-post regulation might dismiss the unsafe devices. The contribution concludes by suggesting a number of improvements to the supervisory system of medical devices in Europe.

Type
Symposium on the EU's New Medical Devices Regulatory Framework
Information
European Journal of Risk Regulation , Volume 4 , Issue 4 , December 2013 , pp. 465 - 477
Copyright
Copyright © Cambridge University Press 2013

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References

1 Poly Implant Prothèse (PIP) was a French company started in 1991 that produced breast implants. PIP went into liquidation in 2011. The company produced circa 100,000 implants per year, during circa 20 years. Approximately 400,000 women worldwide may have been implanted with PIP gel products. <http://en.wikipedia.org/wiki/Poly_Implant_Proth%C3%A8se> (last accessed on 4 November 2013).

2 European Parliament Resolution No 2012/2621(RSP), P7_TAPROV( 2012)0262, available online at <http://www.europarl.plenary/en/texts-adopted.htmleuropa.eu/> (last accessed on 4 November 2013).

3 Commission Proposal for a Regulation of the European Parliament and of the Council on Medical Devices and Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, COM(2012) 542; Commission Proposal for a Regulation of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices, COM(2012) 541.

4 European Parliament Committee on the Environment, Public Health and Food Safety, Draft Report on the Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 – C7-0318/2012 – 2012/0266(COD)). Rapporteur: Dagmar Roth-Behrendt. The report is available on the internet at <http://www.europarl.europa.eu/committees/en/envi/draft-reports.html?linkedDocument=true&ufolderComCode=ENVI&ufolderLegId=7&ufolderId=10806&urefProcYear=&urefProcNum=&uref-ProcCode=#menuzone> (last accessed on 4 November 2013).

5 European Parliament Committee on the Environment, Public Health and Food Safety, Draft Report on the Proposal for a Regulation of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices (COM(2012)0541 – C7-0317/2012 – 2012/0267(COD)), available on the internet at <http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.196+01+DOC+PDF+V0//EN&language=EN> (last accessed on 4 November 2013).

6 European Parliament Report on the proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 – C7-0318/2012 – 2012/0266(COD)), available on the internet at <http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+REPORT+A7-2013-0324+0+DOC+XML+V0//EN> (last accessed on 4 November 2013).

7 The incidents with medical devices occurred with implantable medical devices. In Vitro Diagnostic medical devices are mostly not used by the patients themselves. For this reason I will not focus on the In Vitro Diagnostic Directive.

8 Council Directive 93/42/EEC on Medical Devices, OJ 1993 L 169/1, also known as the “Medical Device Directive”; Council Directive 90/385/EEC on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices, OJ 1990 L 189/17; Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices, OJ 1998 L 331/1 The Medical Device Directive was last amended by European Parliament and Council Directive 2007/47/EC, OJ EC 2007 L 247/21.

9 See also the Council Conclusions on Innovation in the Medical Device Sector, 2011/C 202/03, available on the internet at <http://eur-lex.europa.eu/LexUriServ/Lex-UriServ.do?uri=OJ:C:2011:202:0007:0009:EN:PDF> (last accessed on 4 November 2013).

10 Council Resolution on a New Approach to Technical Harmonization and Standards, OJ C 136, 4.6.185, available on the internet at <http://eur-lex.europa.eu/JO-Html.do?uri=OJ:C:1985:136:SOM:EN:HTML> (last accessed on 4 November 2013).

11 Council Resolution, ibid. 10. The Resolution establishes four fundamental principles:

  1. 1.

    1. Legislative harmonisation is limited to essential safety requirements (or other requirements in the general interest) with which products put on the market must conform and which can therefore enjoy free movement throughout the European Union;

  2. 2.

    2. The task of drawing up technical production specifications is entrusted to organisations competent in industrial standardisation, which take the current stage of technology into account when doing so;

  3. 3.

    3. These technical specifications are not mandatory and maintain their status of voluntary standards;

  4. 4.

    4. The authorities are obliged to recognise that products manufactured in conformity with harmonised standards are presumed to conform to the essential requirements established by the Directive. If the producer does not manufacture in conformity with these standards, he has an obligation to prove that his products conform to the essential requirements. Two conditions have to be met in order that this system may operate:

  5. a.

    a. The standards must guarantee the quality of the product;

  6. b.

    b. The public authorities must ensure the protection of safety (or other requirements envisaged) on their territory. This is a necessary condition to establish mutual trust between Member States.

12 A procedure for the provision of information in the field of technical standards the Member States undertake to keep a constant check on the technical regulations which are applied so as to withdraw those which are deemed obsolete or superfluous; and the Member States ensure the mutual recognition of the results of tests and establish harmonised rules on the operation of certification bodies (the mutual recognition principle).

13 International Medical Device Regulators Forum, available on the internet at <http://www.imdrf.org/index.asp> (last accessed on 4 November 2013).

14 These are the so called CEN-norms formulated by the European Committee for Standardization and published in the Official Journal of the European Union, available on the internet at <http://www.cen.eu/cen/pages/default.aspx> (last accessed on 4 November 2013).

15 European Standards on Medical devices, available on the internet at <http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/> (last accessed on 4 November 2013).

16 There is no obligation to use the “harmonized standards” in the conformity assessment procedure.

17 “Soft law” such as guidelines and recommendations is not considered binding by Parliament and Council. However, “soft law” can impose binding obligations on Member States to supervise their implementation according to the principle of sincere cooperation set forth in Art. 4(3) of the Consolidated version of the Treaty on European Union, OJ C 326 .55, 26.10.2012: “Pursuant to the principle of sincere cooperation, the Union and the Member States shall, in full mutual respect, assist each other in carrying out tasks which flow from the Treaties. The Member States shall take any appropriate measure, general or particular, to ensure fulfilment of the obligations arising out of the Treaties or resulting from the acts of the institutions of the Union. The Member States shall facilitate the achievement of the Union's tasks and refrain from any measure which could jeopardise the attainment of the Union's objectives”.

18 The Notified body involved in this case was TÜV Rheinland, which had provided the CE-mark for PIP-breast implants. TÜV Rheinland announced an appeal against the Ruling.

19 The Draft Report of the European Parliament proposes some amendments to the Commission proposals to attribute more authorities to the European Medicines Agency (EMA). The proposed Regulation distinguishes a centralized procedure for innovative medical devices to be carried out by EMA and a decentralized procedure for high-risk devices to be carried out by the Competent Authority. In addition, one of the amendments proposes a multi-disciplinary European advisory committee of experts and representatives of stakeholder and civil society organisations. The Committee on the Internal Market and Consumer Protection sent its draft opinion to the Committee on the Environment, Public Health and Food Safety (ENVI) with several proposed amendments. 2012/0266(COD) 4.4.2013.

20 European Parliament Resolution No 2012/2621(RSP), P7_TAPROV( 2012)0262, available on the internet at <http://www.europarl.europa.eu/plenary/en/texts-adopted.html> (last accessed on 4 November 2013).

21 <http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+REPORT+A7-2013-0324+0+DOC+XML+V0//EN> (last accessed on 4 November 2013).

22 Eucomed, “Rushed deal leaves patients and jobs in second place”, 25 September 2013, available on the internet at <www.eucomed.org/newsroom/117/187/Rushed-deal-leaves-patients-and-jobs-in-second-place?cntnt01template=detail-pr> (last accessed on 4 November 2013).

23 A report of this meeting is available on the internet at <http://register.consilium.europa.eu/pdf/en/13/st10/st10360.en13.pdf> (last accessed on 4 November 2013).

24 Council Directive No 93/42/EC on medical devices, supra note 8; Council Directive 90/385/EEC on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices, OJ 1990 L 189/17; Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices, OJ 1998 L 331/1.

25 Art. 44 sets forth the mechanism for scrutiny of certain conformity assessments. The “scrutiny mechanism” has been discussed in the Council and the issue is likely to be discussed again by the Council following the plenary vote in the European Parliament.

26 Commission Recommendation No C(2007) (5406) on Relevant Product and Service Markets within the Electronic Communications Sector Susceptible to Ex-ante Regulation in Accordance with Directive 2002/21/EC of the European Parliament and of the Council on a Common Regulatory Framework for Electronic Communications Networks and Services, OJ L 344, 28.12.2007, pp. 65–69.

27 Christa Altenstetter uses the concepts ex-post and ex-ante regulation in: Christa Altenstetter, “Medical Device Regulation: Demystifying the Role of the FDA 1976–2012”, presentation held at the Conference “Revising Medical Devices Regulation, the Legal Challenges”, Tilburg, 29 January 2013.

28 See the proposed Regulation on Medical Devices, supra note 3, Chapter VII, Surveillance in recent and proposed legal framework is set up in a form of self-regulation by economic operators, defined in Art. (1)23.

29 This definition comes from Buchanan, James and Stubblebine, Craig, “Externality”, 29(116) Economica (1962), pp. 371 et sqq CrossRefGoogle Scholar.

30 Stefano Bartolini, “Beyond Accumulation and Technical Progress: Negative Externalities as an Engine of Economic Growth”, Quaderni Università degli Studi di Siena DIPARTIMENTO DI ECONOMIA POLITICA n. 390 – Luglio, available on the internet at <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=467002> (last accessed on 4 November 2013). The author gives a description of negative externalities on the environment.

31 Koldstad, Charles D., Ulen, Thomas S. and Johnson, Gary V., “Ex Post Liability for Harm vs. Ex ante Safety Regulation: Substitutes or Complements?”, 80(4) The American Economic Review (1990), pp. 888 et sqq Google Scholar.

32 One of the first law and economics studies was done by Steven Shavel in 1884: Shavell, Steven, “A Model of the Optimal Use of Liability and Safety Regulation”, 15 Rand Journal of Economy, pp. 271 et sqq CrossRefGoogle Scholar. Also: Shavell, Steven, “Liability for Harm versus Regulation for Safety”, 13 Journal of Legal Studies, pp. 357 et sqq CrossRefGoogle Scholar.

33 Innes, Robert, “Enforcement Costs, Optimal Sanctions, and the Choice between Ex-post Liability and Ex-ante Regulation”, 24 International Review of Law and Economics (2004), pp. 29 et sqq CrossRefGoogle Scholar. One of his conclusions is the following: “The direct ex-ante regulation of care can be more efficient than imposing ex-post liability for harm even when the government's cost of monitoring care (as required under ex-ante regulation) is significantly higher than the cost of monitoring accidents (as needed under ex-post liability).”

34 [FDA Overview of Device Regulation] Available on the internet at <http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm> (last accessed on 4 November 2013): Even for the pre-market notification according to the 510(k) Food, Drug and Cosmetic Act, the FDA still has to approve the admittance of the device. 510 (K) constitutes fastest procedure in the United States to place a medical device on the market. [Overview of Device Regulation], available on the internet at <http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm> (last accessed on 4 November 2013).

35 See the Commission Proposal for a regulation concerning Medical Devices, supra note 3.

36 Par. 13 of Annex I of the Medical Device Directive specifies the information that should be provided by the Manufacturer. Instructions for the use of the medical device must be understandable for the medical specialist; however, some requirements for the patients are also formulated.

37 The Medical Devices Directive sets forth a system for the classification of medical devices in Classes I, IIa, IIb and III. For each class, there is a specific procedure for conformity assessment. When a product is classified in Class I, the manufacturer shall perform the conformity assessment mainly through self-assessment. For Classes IIb, IIa and III, the procedures set by the chosen Notified Body must be followed. Class III products are high-risk, Class IIa and IIb products have an average risk and Class I products have low risk. A decision of the European Commission determined in 2003 that breast implants fall in Class III: Commission Directive No 2003/12/EC on the Reclassification of Breast Implants in the Framework of Directive 93/42/EEC on Medical Devices, OJ L 28, 4.2.2003, pp. 43–44.

38 Daily main reporter, “Thousands to Undergo Blood Tests after Fears Replacement Metal Hips are Poisoning Them”, 17 June 2011, Mail Online, available on the internet at <http://www.dailymail.co.uk/health/article-2004218/Thousands-hip-op-patientsfear-poisoned-metal-prosthetics.html> (last accessed on 4 November 2013): “In April 2010, the United Kingdom's (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert that included specific follow-up recommendations for patients with MoM hip replacements. The recommendations included blood tests and imaging for patients with painful MoM hip implants. In February 2012, MHRA published a medical device alert and updated it in June 2012 with advice on the management and monitoring of patients with MoM hip systems.”

39 Lensen EJ, Withagen MI, Stoutjesdijk JA, Kluivers KB, Vierhout ME., “The use of synthetic mesh in vaginal prolapse surgery: a survey of Dutch urogynaecologists” 262(1), Eur J Obstet Gynecol Reprod Biol, May;162(1):113–115 (2012), [starting page 113: doi: 10.1016/j.ejogrb.2012.02.004. Epub 2012 Mar 6. Avaibable online at <http://www.ncbi.nlm.nih.gov/pubmed/22397742> (last accessed on 4 November 2013). Metal Hips were recalled by NHRA.

40 “Europeans are left to their own devices”, BMJ 2011; 342 doi: http://dx.doi.org/10.1136/bmj.d2748 (Published 15 May 2011) Cite this as: BMJ 2011;342:d2748

41 “Medical Device Regulation, How a fake hip showed up failings in European device regulation,” BMJ 2012; 345, doi: <http://dx.doi.org/10.1136/bmj.e7090> (Published: 24 October 2012). Cite this as: BMJ 2012;345:e7090

42 One can argue that Arts. 63, 67, 69, 70 and 72 of the proposed Regulation regarding medical devices formulate concrete tasks for Competent Authorities.

43 Robert Mendick, Laura Donnelly and Harriet Alexander, “Breast Implant Scandal: Whe Whistleblowers”, The Telegraph, 31 December 2011, available on the internet at <http://www.telegraph.co.uk/health/healthnews/8986746/Breast-implant-scandal-the-whistleblowers.html> (last accessed on 4 November 2013)

44 W. Sorgdrager, “Van incident naar effectief toezicht, Onderzoek naar de afhandeling van dossiers over meldingen door de Inspectie voor de Gezondheidszorg”, in order by Dutch Health Minister published on 19 November 2012, p. 52.

45 Recall by the French Government according to Art. 10 of the Medical Device Directive saying the following: “Afssaps have registered an increase of reported incidents over the last three years concerning silicone filled breast implants manufactured by Poly Implant Prothese (PIP). The elements collected during this inspection showed that most of the breast implants manufactured since 2001 have been filled with a silicone gel different from the one described in the CE-marking file and the batch manufacturing files”.

46 Medical Devices Vigilance System, January 2013, available on the internet at <http://ec.europa.eu/health/medical-devices/documents/guidelines/under2.12>.

47 See for the definition of the principle of sincere cooperation, Art. 3, par. 4 of the Treaty of the European Union, supra note 17.

48 Eucomed, “Innovation, Reseach & SMEs”, available on the internet at <http://www.eucomed.org/key-themes/innovation-research-smes> (last accessed on 4 November 2013). According to Eucomed data, 95% of all manufacturers of medical devices are Small and Medium Entreprises (SME).

49 Par. 13.3. states the following: The label must bear the following particulars: (a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community.

50 European Commission, DG Health & Consumers, “Guidance MEDDEVs”, available on the internet at <http://ec.europa.eu/health/medical-devices/documents/guidelines/> (last accessed on 4 November 2013).

51 See for the definition of the principle of sincere cooperation, Art. 3, par. 4 of the Treaty of the European Union, supra note 17.

52 According to Article 288 TFEU.

53 Article 8 of the Medical Device Directive, supra note 8.

54 Article 10 of the Medical Device Directive, supra note 8.

55 Article 18 of the Medical Device Directive, supra note 8.

56 Paragraph 2.3.5 of Annex X to the Medical Device Directive, supra note 8.

57 Commission Proposal, supra note 3.

58 See the proposed Art. 44 on the mechanism for scrutiny of certain conformity assessments.

59 (2012/0266(COD) 4.4.2013. In addition, the Committee on the Internal Market and Consumer Protection sent its DRAFT OPINION to the Committee on the Environment, Public Health and Food Safety (ENVI) with several proposed amendments, amendment 53 2012/0266(COD) 4.4.2013).

60 Henriette Jacobsen, “MEPs divided ahead of vote on medical devices”, EurActiv special report, 5 July 2013, available on the internet at <http://www.euractiv.com/special-report-medicaldevices-r/meps-divided-medical-devices-reg-news-529087> (last accessed on 4 November 2013).

61 Dutch ‘kamerstuk’ (Parliamentary documents), available on the internet at <https://zoek.officielebekendmakingen.nl/kst-21501-31-283.html> (last accessed on 4 November 2013).

62 The draft report of the ENVI <Commission>﹛ENVI﹜Committee proposed an amendment to introduce an obligation for innovative medical devices and Class III devices to undergo a new procedure for marketing authorisation, carried out by the Competent Authority in the Member States: “The refusal of a marketing authorisation shall constitute a prohibition on the placing on the market of the devices referred to in Article 41a(1) throughout the Union.” Also, “None of the following devices may be placed on the market of a Member State unless a national marketing authorisation has been granted by the competent authority of that Member State through the decentralised procedure referred to in Article 41d, and in accordance with the provisions of this Regulation”.

63 Commission proposal for a Regulation on Medical Devices, supra note 3, Annex I, par. 19.

64 Commission proposal for a Regulation on Medical Devices, supra note 3, Art. 62.

65 Commission proposal for a Regulation on Medical Devices, supra note 3, Annex VII.

66 Commission proposal for a Regulation on Medical Devices, supra note 3, Art. 62, par. 3.

67 Commission proposal for a Regulation on Medical Devices, supra note 3, Art. 65.

68 Commission proposal for a Regulation on Medical Devices, supra note 3, Art. 61, par. 5.

69 Commission proposal for a Regulation on Medical Devices, supra note 3 Art. 78a.

70 Amendment 653, AM\\936128EN.doc

71 ESC's response to European Commission's Proposals for new regulation to govern medical devices, available on the Internet at <http://www.escardio.org/about/press/press-releases/pr-13/Pages/esc-proposals-medical-devices-directives.aspx> (last accessed on 4 November 2013).

72 Amendment (53) sets forth that Member States should take all necessary measures to raise awareness among healthcare professionals, users and patients about the importance of reporting suspected serious incidents. In the legislative Resolution this has been incorporated as Amendment 46.

73 Amendment 27 RMDD. In the legislative Resolution this has been incorporated as Amendment 81.

74 Amendment 98 Proposal for a regulation Article 61 – paragraph 3, in the legislative Resolution Amendment 61.

75 Amendment 165, in the legislative Resolution Amendments 25a, 87, 103, 106.

76 Amendments 321 and 438. This Amendment has not been registered in the legislative Resolution Amendment.